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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1
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  • Article rating: 3.0

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1

Investigator Site self-assessment of their healthcare systems against clinical research regulations and guidance

We are proud to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. It is provided free on this website via the "eSRA" tab. This Version 2018.1 is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Investigator Site Survey .. Please Participate
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  • Article rating: 5.0

Investigator Site Survey .. Please Participate

Partnering for Success

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

Netherlands initiative to assess electronic health record systems using eCF eSRA tool
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Netherlands initiative to assess electronic health record systems using eCF eSRA tool

Partnering for Success

The Dutch Clinical Trial Foundation (DCTF) evaluate the use of eSRA for the validation of electronic health record (EHR) systems used at clinical research sites within the Netherlands. The group consists of representatives from several pharmaceutical companies, CROs and hospitals. Expand the article to learn more...

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Birds-of-a-Feather Discussion:  Principal Investigator signature / approval on eCOA Data

Facilitator: Shelby Abel, Bioverativ a Sanofi Company

For This Topic:   “Experience with exceptions of PI signature/Approval on eCOA Data. Please bring your experience and thoughts.”  This is a facilitated discussion with the content coming from the sharing of participants experiences, comments, and questions on this topic.

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